A Brief Parental Intervention on Learning and Education in Childhood Cancer

Cancer Clinical Trial

Official title:

Acceptability and Feasibility of a Brief Psychoeducational Intervention for Parents of Children With Childhood Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05268315
• Other study ID #: 20-224
• Status: Withdrawn
• Phase: N/A
• Start date: February 24, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: January 2024
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess whether a brief intervention about learning and education is both practical and acceptable for parents of children with cancer.

Description:

After being provided details about the study, participants signing the study consent form complete pre-intervention questionnaires. Participants then complete a brief psychoeducational intervention, via a HIPAA-compliant web and video conferencing platform on Zoom. The intervention is followed by completion of a post-intervention evaluation form. The consent form and study questionnaires are completed through Research Electronic Data Capture (REDCap), a secure web-based application.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• parent(s) or legal guardian(s) of children with cancer
• preferred language for oral and written communication is English
• 18 years of age or older
• 1 or 2 parents or legal guardians can participate for each child

The child must also meet the following for the parent(s)/legal guardian(s) to participate:

• diagnosis of cancer
• child is actively receiving cancer treatment at University of New Mexico Hospital or recently completed treatment (within 0-6 months post-treatment)
• child is between the age of 3 and 14
• child resides in New Mexico Exclusion Criteria: Parents of children who are wards of the state are excluded (including children in custody of the NM Children, Youth & Families Department).

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Brief Psychoeducational Intervention
The 1-session psychoeducational intervention is divided into three brief modules. Topics that are covered include thinking, learning, emotional, and behavioral functioning as they relate to childhood cancer, educational and school supports, and the role of neuropsychological and school-based assessments.

Locations

Country	Name	City	State
United States	University of New Mexico Hospital	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
University of New Mexico	Hyundai Hope On Wheels

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of study recruitment and enrollment	Among qualifying families, the number receiving recruitment information about the study, identifying interest, scheduling, and completing procedures. Note, for each qualifying family, one or two parents or legal guardians are able to enroll in the study. This is a parental intervention and the child with cancer does not participate in the study.	Through study completion, up to 2 years
Primary	Fidelity to the intervention protocol	Interventions are audio-recorded. Percent adherence to the intervention protocol per a fidelity form, developed for this study, is assessed by an independent rater of fidelity.	at time of intervention (day 1)
Primary	Acceptability of the intervention	Ratings are provided on intervention acceptability as part of the Program Evaluation Form, a questionnaire developed for this study.	immediately post-intervention (day 1)